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Improving care for rural patients with solid tumors

Improving the Timeliness and Quality of Care for Rural Cancer Patients With Solid Tumors

Not applicable Interventional University of Colorado, Denver · NCT04916990

This study is testing a new support program to see if it helps rural patients with solid tumors start and finish their treatment faster compared to usual care.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment320 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorUniversity of Colorado, Denver Academic / other
Drugs / interventionschemotherapy, radiation
Locations14 sites (Aurora, Colorado and 13 other locations)
Trial IDNCT04916990 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the CARES intervention in enhancing the speed of treatment initiation and completion for patients with solid tumors in rural areas. A total of 320 participants will be randomly assigned to either the CARES intervention group, which includes navigation and counseling sessions, or a usual care group that receives standard resources. Participants will complete surveys to assess quality of care and patient-reported outcomes at baseline, 3 months, and 6 months. The intervention aims to provide tailored support through oncology nurse navigators and counselors over a 6-month period.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old, English or Spanish speaking, diagnosed with specific types of solid tumors, and residing in designated rural areas served by participating hospitals.

Not a fit: Patients who do not reside in the specified rural counties or who are not diagnosed with the targeted solid tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the time to treatment for rural patients diagnosed with solid tumors.

How similar studies have performed: Other studies have shown promising results with similar navigation and support interventions for cancer patients, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria Assessed During Screening:

1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Male and female adults over 18 years old
4. English or Spanish speaking
5. Receives cancer treatment at UCH- Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, or Parkview Medical Center.
6. Resides in any of the rural counties served by the UCH-Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, VA, Huntsman Cancer Institute, or Parkview Medical Center with Rural-Urban Continuum Codes (RUCC) codes 4-9.
7. Diagnosed with lung cancer (LC): small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), using incident LC diagnosis according to the International Classification of Diseases for Oncology \[ICD-O\] codes: C34.0, C34.1, C34.2, C34.3, C34.8, C34.9, and C33.9, and other lung cancer variants
8. Stage of diagnosis for SCLC (limited vs. extensive), NSCLC (Stages 0, I, II, IIA, IIIB, IV), according to the American Joint Committee on Cancer Staging \[AJCC\] Tumor Node Metastasis \[TNM\] stages: I-IV)
9. Will receive the following types of breast, bladder, cervix, colon, rectum, lung, head-and-neck cancer treatments (surgery, radiation therapy, chemotherapy, or a combination of those modalities, including neoadjuvant and adjuvant therapy)
10. Diagnosed with head and neck cancer (HNC) using head and neck squamous cell carcinoma (HNSCC) ICD-O codes for the oral cavity (including lip; codes C00.0-C00.6, C00.8, C00.9, C02.0-C02.3, C02.8, C0.2.9, C03.0, C03.1, C03.9-C04.1, C04.8-C05.0, C06.0-C06.2, C06.8, and C06.9), the oropharynx (codes C01.9, C02.4, C05.1, C05.2, C5.8, C5.9, C09.0, C09.1, C09.8-C10.4, C10.8, C10.9, C14.0, C14.2, and C14.8), the hypopharynx (codes C12.9-C13.2, C13.8, and C13.9), and the larynx (codes C32.0- C32.3 and C32.8-C32.9) and histology codes for squamous cell carcinoma (SCC) or its variants (codes 8032, 8050, 8052, 8070-8075, and 8083-8084), and salivary gland cancer (code C07 and variants), and other head and neck cancer variants
11. Stage of diagnosis for HNC (Stages I, II, III, IV) according to the AJCC's TNM stages I-IV
12. Diagnosed with malignant neoplasm of thyroid gland, ICD-10 code: C73, and other thyroid cancer variants
13. Diagnosed with BC using malignant neoplasm of breast ICD-O codes for connective tissue of the breast, codes: C50.0, C50.1, C50.2, C50.3, C50.4, C50.5, C50.6, C50.8, C50.9, and other breast cancer variants.
14. Diagnosed with CC using malignant neoplasm of cervix uteri ICD-O codes: C53.0, C53.1, C53.8, C53.9 and other cervical cancer variants.
15. Diagnosed with CRC using colon and rectum malignant neoplasm ICD-O codes for colon (codes: C18, C18.1, C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C18.9) and rectum (code C20), and other colon and rectum cancer variants.
16. Diagnosed with BLC using malignant neoplasm of ICD-O codes: C67.9 and other bladder cancer varients.

    Inclusion Criteria Confirmed via Baseline Survey:
17. Rural and medically underserved, defined as meeting the following criteria:

    * Rural: Resides in a rural county with a RUCC code 4-9 AND,
    * Underserved population who come from counties meeting any of the "health professional shortage areas" OR "Medically Underserved Areas/Populations" AND/OR
18. Uninsured: No health insurance (public or private insurance) AND/OR
19. Underinsured: (c.1) Public insurance (e.g., Medicaid, Medicare Part B exclusive, VA) (c.2) 10% or more of annual income is spent on out-of-pocket medical expenses

Exclusion Criteria Assessed During Screening:

1. Children under 18 years old
2. Individuals who do not speak English or Spanish
3. Individuals not receiving cancer treatment at UCH (Aurora, Highlands Ranch, UCHealth North, UCHealth Memorial Hospital), San Juan Cancer Center, RMCC-Pueblo, St. Mary's or Parkview Medical Center.
4. Diagnosed with primary cancer other than breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer or other type of cancer not listed in the inclusion criteria.
5. Diagnosed with a type of breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer listed under inclusion criteria but will not be treated at one of the collaborating hospital sites,
6. Has already initiated curative treatment for the current episode of cancer.

   Exclusion Criteria Assessed via Baseline Survey:
7. Individuals from vulnerable populations (e.g., inmates or on probation, homeless\*, and pregnant\*)
8. Decisionally-challenged with cognitive or personality impairment, suicidal ideation or intoxication (alcohol or drugs) at the time of consent or endorsed in baseline survey that interfere with ability to participate in the study.
9. Unable to hear (not including individuals who can hear with an auditory aid).\*
10. Likely inability to track the individual over time (e.g. no permanent address at the time of consent) \*Individuals who become homeless, pregnant, or lose their hearing or permanent address after they have consented and/or assigned to study condition may remain in the study until completion

Where this trial is running

Aurora, Colorado and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lung CancerHead and Neck CancerThyroid CancerCervical CancerBreast CancerBladder CancerColon CancerRectum Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.